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Somatosensory Amplification and Psychological and Functional Status In Patients With Knee Osteoarthritis

NCT ID: NCT06753019

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-01-10

Brief Summary

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As modern society enters the age of an aging population, the prevalence of knee OA continues to increase, which necessitates multi-faceted research. Although there are studies on exaggeration of bodily sensations, depression, kinesiophobia and functional status in patients with knee OA, there are deficiencies in correlating these factors with each other and in directing evaluation and treatment programs. Based on this, this study aims to demonstrate the relationship between the level of exaggeration of bodily sensations, psychological-functional status and perceived pain level in patients with knee pain due to knee OA.

Detailed Description

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This study is a screening study designed to reveal the relationship between the level of somatosensory amplification and the psychological-functional status and the level of pain felt in patients with knee pain due to knee OA. Considering the correlation of the features to be examined in the literature, it was found that the required sample size should be at least 80 with a test power of 95%, a type I error of 0.05 and an effect size of 0.34. 88 patients between the ages of 40-84 who have been diagnosed with knee OA and have complaints for at least 6 months will be included in the study. Patients with knee pain due to any rheumatologic disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma will be excluded from the study. The patients' sociodemographic characteristics such as age, height, weight, body mass index (BMI), gender, education level, marital status will be evaluated using the sociodemographic information form, somatosensory amplification levels will be evaluated with the 'Somatosensory Amplification Scale (SSAS)', the presence of kinesiophobia with the 'Tampa Kinesiophobia Scale (TSK)', pain levels with the Visual Analog Scale (VAS), the presence of depression with the 'Beck Depression Inventory (BDI)', and functional status with the total score of the 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)'. Statistical analysis of the data will be done using IBM SPSS Statistics version 20.0 (SPSS Inc., New York, USA). Kolmogorov-Smirnov test will be used to determine whether the variables are normally distributed, and the socio-demographic information of the participants and the scores they received from the SSAS, TAMPA, VAS, BDI and WOMAC questionnaires will be expressed as percentages, ratios or averages. The linear relationship between quantitative variables will be analyzed with Pearson correlation analysis, and the correlation between qualitative and quantitative variables will be analyzed with variance analysis (ANOVA), and independent samples t-test. In all analyses, p\<0.05 will be considered statistically significant.

Conditions

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Knee Osteoarthritis Amplification Kinesiophobia Psychological Disability Pain

Keywords

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knee osteoarthritis somatosensory amplification kinesiophobia pain depression

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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assessment group

Patients diagnosed with knee OA, who have complaints for at least 6 months, and between the ages of 40-84 will be included in the study.

survey assessment tools

Intervention Type OTHER

Functional and psychological status and the level of somatosensory amplification in patients with knee osteoarthritis will be evaluated with questionnaires.

Interventions

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survey assessment tools

Functional and psychological status and the level of somatosensory amplification in patients with knee osteoarthritis will be evaluated with questionnaires.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosed with knee OA and had complaints for a minimum of 6 months

Exclusion Criteria

* any rheumatological disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma
Minimum Eligible Age

40 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

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Mesut ERGAN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mesut ergan

Role: STUDY_DIRECTOR

Suleyman Demirel University

Locations

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Suleyman Demirel University Faculty of Health Science

Isparta, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mesut ERGAN, asst. prof.

Role: CONTACT

Phone: +90 02462113730

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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09-27-2024/80/3

Identifier Type: -

Identifier Source: org_study_id